HPF S.R.L.

Certificate G10 082526 0002

Rev. Rev. 00Issued

Valid until: Oct 26, 2028

Certificate G10 082526 0002 is a valid Quality management system issued to HPF S.R.L. and registered in EUDAMED. Valid until October 26, 2028. View the full certificate record on MD Atlas.

Overview

Certificate number: G10 082526 0002
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0123G10 082526 0002Rev. 00

Validity

Issued: Jan 19, 2024
Valid from: Jan 19, 2024
Valid until: Oct 26, 2028

Notified body

Notified body: TÜV SÜD Product Service GmbH
Notified body SRN: 0123
Notified body country: Germany

Covered devices

No specific devices are listed for this certificate.

Characteristics

Sterile: No
Human tissues: No
Animal tissues: No
In vitro diagnostics: No
Initial registration: Yes
New device: No
Discard allowed: No
SSCP enabled: Yes
Mechanism of scrutiny: No
Intended medical purpose: No
SPP applicable: No
Conditions applicable: No
MOS outside EUDAMED: —
QMS/MOS type: Others

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIa15

15 scopes

V060101 - ORTHOPAEDIC PROSTHESES TESTING DEVICES
Class IIa
P091303 - ORTHOPAEDIC IMPLANT DRILL BITS, SINGLE-USE
Class IIa
P091301 - ORTHOPAEDIC IMPLANT REAMERS, SINGLE-USE
Class IIa
L26 - SURGICAL SCREWDRIVERS, REUSABLE
Class IIa
L0999 - ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER
Class IIa
L098001 - ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY MANDRELS, REUSABLE
Class IIa
L0922 - ORTHOPAEDIC SURGERY GUIDES, REUSABLE
Class IIa
L0919 - ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENT KITS, REUSABLE
Class IIa
L0916 - ORTHOPAEDIC SURGERY BURS AND TIPS, REUSABLE
Class IIa
L091399 - ORTHOPAEDIC SURGERY FORCEPS, REUSABLE - OTHER
Class IIa
L091199 - ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER
Class IIa
L091104 - ORTHOPAEDIC PROSTHESES POSITIONERS, REUSABLE
Class IIa
L091102 - ORTHOPAEDIC PROSTHESES REAMERS AND BURS, REUSABLE
Class IIa
L091101 - ORTHOPAEDIC PROSTHESES AND TRAUMATOLOGICAL IMPLANTS EXTRACTORS, REUSABLE
Class IIa
L090401 - ORTHOPAEDIC SURGERY OSTEOTOMES, REUSABLE
Class IIa

Documents

LanguagesEN

Scope coverage

Class IIa15

15 scopes

V060101 - ORTHOPAEDIC PROSTHESES TESTING DEVICES
Class IIa
P091303 - ORTHOPAEDIC IMPLANT DRILL BITS, SINGLE-USE
Class IIa
P091301 - ORTHOPAEDIC IMPLANT REAMERS, SINGLE-USE
Class IIa
L26 - SURGICAL SCREWDRIVERS, REUSABLE
Class IIa
L0999 - ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER
Class IIa
L098001 - ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY MANDRELS, REUSABLE
Class IIa
L0922 - ORTHOPAEDIC SURGERY GUIDES, REUSABLE
Class IIa
L0919 - ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENT KITS, REUSABLE
Class IIa
L0916 - ORTHOPAEDIC SURGERY BURS AND TIPS, REUSABLE
Class IIa
L091399 - ORTHOPAEDIC SURGERY FORCEPS, REUSABLE - OTHER
Class IIa
L091199 - ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER
Class IIa
L091104 - ORTHOPAEDIC PROSTHESES POSITIONERS, REUSABLE
Class IIa
L091102 - ORTHOPAEDIC PROSTHESES REAMERS AND BURS, REUSABLE
Class IIa
L091101 - ORTHOPAEDIC PROSTHESES AND TRAUMATOLOGICAL IMPLANTS EXTRACTORS, REUSABLE
Class IIa
L090401 - ORTHOPAEDIC SURGERY OSTEOTOMES, REUSABLE
Class IIa

Certificate G10 082526 0002

Overview

Validity

Notified body

Covered devices

Characteristics

History

Scope coverage

Documents

Certificate G10 082526 0002

Overview

Validity

Manufacturer

Notified body

Covered devices

Characteristics

History

Scope coverage

Documents

Manufacturer